This clinical trial is a single-center, open-label, non-randomized first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of SNA028 (which is a two-step radioactivity pretargeting agents conducted by GPA33-CC and 177Lu-SmartD2) in patients with GPA33-positive colorectal cancer who have experienced disease progression/recurrence following prior standard therapy.
Age range of 18 to 75 years old (including boundary values);
Individuals with behavioral capacity who voluntarily participate in this clinical study and sign an informed consent form (ICF);
Individuals with ECOG scores ranging from 0 to 1 (see Appendix 1 for details);
Life expectancy>6 months;
Poor nutritional status and inability to tolerate the test subjects;
Individuals who have previously been allergic to SNA028 components or their analogues;
Patients who have received therapeutic drugs and radiation therapy labeled with 177Lu and other radioactive isotopes 4 weeks before SNA028 treatment;
Patients who have received other experimental anti-tumor drug treatments 4 weeks before SNA028 treatment;
Sequential
GPA33-CC；177Lu-SmartD2
DrugSNA028 is a two-step radioimmunotherapy, delivered as two separate products GPA33-CC and 177Lu-SmartD2, both will be administered as an IV infusion.
7
Treatment groupsSee each treatment group below.
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of AE/SAE after administration
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of abnormal Laboratory tests after administration
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of abnormal Vital signs after administration
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of abnormal Physical examination after administration
To evaluate the biodistribution of SNA028
Absorbed dose in major organs throughout the body (red bone marrow, kidneys, liver, intestines, etc.)
To evaluate the biodistribution of SNA028
Major organ and tumour standardised uptake (SUVmax and SUVmean)
To evaluate the biodistribution of SNA028
The retention time of major organs and tumor.
To evaluate the biodistribution of SNA028
The tumour-to-background ratio (TBR) of SUV
Assessing tumour response according to RECIST1.1
The ORR of tumor
Assessing tumour response according to RECIST1.1
The DCR of tumors.
Assessing tumour response according to RECIST1.1
The DOR of tumors.
Explore the PFS of subjects
PFS according to the RECIST1.1
Click on the lead sponsor to view all of their trials.
SmartNuclide Biopharma
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
